USA looks at new antibiotics approval pathway

As superbugs return to the spotlight, US Senators Michael Bennet and Orrin Hatch have introduced a bill to create a new drug approval pathway “to streamline access and encourage innovation and development” of antibiotics.

In an effort to address “some of the significant regulatory obstacles facing antibiotic development and hindering patient and veteran access”, the Promise for Antibiotics and Therapeutics for Health (PATH) Act is going in front of Congress. It would permit the US Food and Drug Administration to accelerate an antibacterial’s approval for “an identifiable, limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need”.

In addition, the bill requires a drug’s label to include special designation from the FDA indicating their intended use in limited, high-risk populations approved under this pathway. The proposed legislation also calls for “further guidance and potential expansion to other appropriate therapeutic areas”.

Sen Bennet (Democrat, Colorado) said the bill will allow new antibiotics that show promise combating these bacteria “to reach patients more quickly and save lives. It will also encourage bioscience companies to invest in innovative research to develop these lifesaving drugs”. Sen Hatch (Republican, Utah) added that the PATH Act “is needed to spur the innovation of new antibiotics”.

The senators noted that while antibiotic resistance “continues to cost tens of thousands of lives in the USA each year, less than ten new drugs have made it to market since 2000”. They added that it is also “a significant concern to our troops, affecting more than a third of returning Iraq and Afghanistan veterans”.

The bill comes as a major review has been published in the UK that ten million people around the world will die every year by 2050 unless new antibiotics are created to tackle drug-resistant infections.